Commission Implementing Regulation (EU) 2020/704Show full title

Commission Implementing Regulation (EU) 2020/704

of 26 May 2020

granting a Union authorisation for the biocidal product family ‘INSECTICIDES FOR HOME USE’

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products(1), and in particular the first subparagraph of Article 44(5) thereof,

Whereas:

(1) On 6 October 2016, Agrobiothers Laboratoire, submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘INSECTICIDES FOR HOME USE’ of product-type 18, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under the case number BC-TW023858-93 in the Register for Biocidal Products.

(2) ‘INSECTICIDES FOR HOME USE’ contains permethrin and S-Methoprene, as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.

(3) On 10 December 2018, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

(4) On 11 July 2019, the Agency submitted to the Commission an opinion(2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘INSECTICIDES FOR HOME USE’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5) The opinion concludes that ‘INSECTICIDES FOR HOME USE’ is a ‘biocidal product family’ within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(6) On 25 July 2019, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘INSECTICIDES FOR HOME USE’.

(8) In the opinion the Agency recommends that a new shelf-life study of INSECTICIDE HOUSEHOLD SPRAY in packagings in which the product will be made available on the market, be conducted by the authorisation holder as a condition of the authorisation. The study should determine the active substance contents, the cis/trans ratio of permethrin and the technical properties of INSECTICIDE HOUSEHOLD SPRAY before and after storage. The Commission agrees with that recommendation and considers that the submission of the results of that study should be a condition relating to the making available on the market and use of the biocidal product family pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1)(d) of that Regulation on the basis of the existing data.

(9) According to the opinion of the Agency, as regards the non-active substance nitromethane contained in the biocidal product family ‘INSECTICIDES FOR HOME USE’, it was not possible to conclude whether it meets the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100(3) within the period for the evaluation of the application. Further examination of nitromethane should therefore take place. If it is eventually concluded that nitromethane is considered as having endocrine-disrupting properties, the Commission will consider whether the Union authorisation for the biocidal product family ‘INSECTICIDES FOR HOME USE’ has to be cancelled or amended in accordance with Article 48 of Regulation (EU) No 528/2012.

(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

(1)

OJ L 167, 27.6.2012, p. 1.

(2)

ECHA opinion of 26 June 2019 on the Union authorisation of ‘INSECTICIDES FOR HOME USE’ (ECHA/BPC/228/2019), https://echa.europa.eu/bpc-opinions-on-union-authorisation

(3)

Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).